Sertraline

Manufacturing Establishments (1)

Labeler

NuCare Pharmaceuticals,Inc.

DUNS Number

010632300

NDC Product Code

68071-4400

Application Number

ANDA077670

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 17, 2022

Ingredients

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQKClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive

Code: L11K75P92JClass: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671PClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive

Code: 5856J3G2A2Class: IACT

Code: UTI8907Y6XClass: ACTIMQuantity: 50 mg in 1 1

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8HClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT